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    K Number
    K101462
    Device Name
    ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
    Manufacturer
    CALDERA MEDICAL, INC.
    Date Cleared
    2010-08-16

    (82 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K083722
    Why did this record match?
    Device Name :

    ASCEND BLUE AC MESH; ASCEND BLUE PC MESH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ascend® Blue AC and Ascend® Blue PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

    Device Description

    Ascend® Blue Mesh is designed to be used in the inpatient or outpatient surgery setting for use in women suffering from pelvic organ prolapse. The mesh is implanted using reusable Caldera Medical introducers, which are surgically removed once the mesh is in place. Ascend® Blue Mesh is available in two different designs – one for anterior compartment defects (AC) and one for posterior compartment defects (PC).

    Ascend® Blue Mesh AC design is composed of macroporous monofilament polypropylene warp knit mesh in a multi-zone construction, which includes blue polypropylene fibers in the central portion and clear polypropylene fibers on the remainder of the device. This formation improves the visualization of the central portion intraoperatively and postoperatively. The central portion provides direct support for the prolapsed organ, while the lateral arms will aid in delivery of the implant and provide tension free fixation.

    The Ascend® Blue product, PC configuration, consists of the same material components as the AC design: macroporous monofilament polypropylene warp knit mesh in a multizone construction, polyethylene sleeves, suture, and polyethylene tips. Each arm is covered by a polyethylene sleeve to protect the arm and reduce tissue resistance during positioning. The suture, sleeves and tips are removed from the device once the unit has been surgically implanted, for this construction serves as a delivery mechanism only. The only component to remain within the body is a portion of mesh.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Ascend® Blue Mesh, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Ascend® Blue Mesh are primarily based on demonstrating substantial equivalence to its predicate device, Ascend® Mesh (K083722). The reported device performance indicates that the Ascend® Blue Mesh met these equivalency criteria through various tests.

    Acceptance Criteria CategorySpecific Criteria/OutcomeReported Device Performance (Ascend® Blue Mesh)
    Indications for UseSame as predicate device (repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse).Same as predicate device.
    Design/MaterialsSubstantially equivalent design/materials to predicate. (Predicate: Pre-shaped, sterile, single use implant of knitted large-pore monofilament polypropylene clear mesh with clear polyester heatshrink formed tips).Changes: Central mesh is woven with blue tinted polypropylene yarn for improved visualization. Color-coded molded tips replace heat-shrink formed tips. Mesh weave pattern is unchanged. Despite these changes, the overall material (macroporous monofilament polypropylene warp knit mesh) is the same, and the changes are deemed to maintain substantial equivalence.
    Mesh Color AdditiveCompliance with relevant regulations (e.g., 21 CFR 74.3045).Utilizes a blue tinted polypropylene yarn, implying compliance with 21 CFR 74.3045.
    SterilitySterility Assurance Level (SAL)
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